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Biotech / Medical : Rosetta Genomics (ROSG) - microRNA -- Ignore unavailable to you. Want to Upgrade?

To: tuck who wrote (41)	1/18/2009 9:36:57 PM
From: Steve Lokness	Respond to of 58

Tuck; I mean a controlled and blinded trial. Welll, the press release says ........." today unveiled initial data relating to the company's colorectal cancer screening diagnostics test, miRscreen(TM) colon, which is based on a simple blood draw, and is expected to be released next year." Either the test works or it doesn't work. If it works - then we can compare it to the current test. But in any case and at least according to Rosetta, the time to market doesn't look long. Should be information for someone a little sharper on this than I am tonight - it would be nice to hear comments; The data presented at the conference will be available for downloading from the company's website, at rosettagenomics.com as of Sunday January 18th morning.

To: tuck who wrote (41)	1/18/2009 11:34:41 PM
From: rkrw	Respond to of 58

FDA wants prospectively defined retrospective data. Identify the genes you want to study up front, collect the samples, then unblind. Getting data published would help sell it to docs. Limited data, not prospectively defined, not published, will have very little chance for taking off. Most of these tests sound great on first blush but won't sell at all. Here's a little snippet from the kras panel: FDA agreed to accept the data under the following conditions: the trials must be adequate and well-controlled; the sample size must be sufficiently large to ensure randomization; tumor tissue must be obtained in more than 95 percent of registered study participants and an evaluable result must be available for greater than 90 percent of study subjects; the assay must be reviewed and validated by the FDA; genetic analyses must be performed according to a qualified assay methods by blinded investigators; and that sponsors and the FDA must create an analytical plan to test hypotheses for updating labels and making promotional claims